Human Research Protections Program (HRPP)

Policy and Procedures

THE INTRAMURAL NIH HUMAN RESEARCH PROTECTION PROGRAM (HRPP)

The NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability (for more information see http://www.nih.gov/about/mission.htm). The NIH’s Intramural Research Program (IRP) has a Human Research Protection Program (HRPP) to protect the rights and safeguard the welfare of human subjects who participate in its research studies. The HRPP is made up of NIH Institutes and Centers, NIH officials, NIH Institutional Review Boards, and researchers and staff who conduct and support research involving human subjects.

The intramural NIH HRPP is governed, in part, by a variety of standard operating procedures (SOPs), which can be accessed via the links below. These SOPs generally apply to NIH intramural staff and NIH intramural program activities. They generally do not apply to human subjects research carried out by NIH grantees. For more information on requirements for NIH grantees, see the NIH Office of Extramural Research (OER).

The SOPs are primarily based on the Belmont Report and U.S. Federal Regulations that protect human subjects (45 C.F.R. 46 and applicable FDA regulations under 21 C.F.R. parts 50, 56, 312 and 812). For questions regarding the intramural NIH policies or procedures, contact the Office of Human Subjects Research Protections (OHSRP) at 301-402-3444. Instructions To access an NIH HRPP SOP, click a title below:

List of NIH HRPP Policies and Procedures by Topic Public

Revised as of 2-10-2016! Introduction to the NIH Human Research Protection Program

Revised as of 2-29-16! SOP 1- HSR and the NIH IRB System

Revised as of 2-24-16! SOP 2 – IRB Membership and Structure

Revised as of 10-19-2015! SOP 3 – Management and Administrative Operations of the IRB

Revised as of 10-23-2015! SOP 4 – Human Research Protection Program (HRPP) Documentation and Records

SOP 5 – NIH Research Activities with Human Data/Specimens

SOP 6 – Determinations, Including Exemptions Made by the Office of Human Subjects Research Protections (OHSRP)

Revised as of 9-25-2015! SOP 7 – Requirements for the Ethical and Regulatory Review of Research by NIH Institutional Review Boards (IRBs)

Revised as of 9-28-2015! SOP 7A – Requirements for Expedited Review of Research by NIH Institutional Review Boards

SOP 7B – This policy has been incorporated into SOP 7 – this link is no longer active

Revised as of 2-4-2016! SOP 8 – Procedures and Required Documentation for Submission and Initial Review of Protocols

Revised as of 3-8-2016! SOP 9 – Continuing Review by the Convened IRB

Revised as of 2-24-16! SOP 10 – Amendments to IRB-approved Research

Revised as of 9-4-2015! SOP 11- Suspensions and Terminations of IRB Approval and Administrative Holds

Revised as of 9-4-2015! SOP 11A – Closure of an IRB-approved protocol

Revised as of 3-8-2016! SOP 12-Requirements for Informed Consent

Revised as of 11-15-2015! SOP 13 – Recruitment, Selection and Compensation of Research Subjects

Revised as of 2-25-16! SOP 15 – Research Regulated by the Food and Drug Administration (FDA): General Procedures for Both IND and IDE Applications

Revised as of 2-24-16! SOP 15A – Research Regulated by the Food and Drug Administration (FDA): Information and Policies Specific to Research Involving Investigational New Drugs (Including Biological Products)

Revised as of 2-24-16! SOP 15B – Research Regulated by the Food and Drug Administration (FDA): Information and Policies for Investigational Device Exemption (IDE) Applications

Revised 3-15-2016! SOP 16A – Allegations of Non-compliance with Requirements of the NIH Human Research Protection Program (HRPP)

Revised as of 3-8-2016! SOP 17 – Data and Safety Monitoring

Revised as of 3-4-2016! SOP 18 – Privacy and Confidentiality

Revised as of 3-8-2016! SOP 19 – Investigator Responsibilities

SOP 20 – NIH HRPP Requirements for Collaborative Research

Revised as of 3-6-2016! SOP 20A – Obtaining a Reliance (Authorization) Agreement at the NIH

Revised as of 3-4-2016! SOP 20B – NIH IRB Responsibilities When Reviewing Local Context Considerations for Offsite Research

Revised as of 3-4-2016! SOP 20C – Responsibilities When the NIH Intramural Research Program Serves as a Coordinating Center for a Multisite Trial or as the IRB of Record for a Non-NIH Coordinating Center

Revised as of 3-15-2016! SOP 20D- NIH FWA Coverage for Non-NIH Employees Working on NIH Protocols

Revised as of 10-20-2015! SOP 21 – Conflict of Interest Requirements for Researchers and Research Staff

Revised as 10-23-2015! SOP 22 – Research Subject Information and Services and Research-related Complaints from Research Subjects

Revised as of 2-24-16! SOP 23 – Quality Management System for the NIH HRPP

Revised as of 9-21-2015! SOP 24 – OHSRP Reporting to the Office for Human Research Protections (OHRP) and Food and Drug Administration (FDA) Regarding Unanticipated Problems,